Trials / Completed
CompletedNCT05011162
"REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 130 (actual)
- Sponsor
- Swing Therapeutics, Inc. · Academic / Other
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the clinical impact of a digital therapy for the management of fibromyalgia. Study participants receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia. The primary endpoint is the Patient Global Impression of Change (PGIC) at week 12. This is a virtual, single-arm, pragmatic, non-significant risk study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Digital ACT | Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT). |
Timeline
- Start date
- 2021-07-25
- Primary completion
- 2024-03-05
- Completion
- 2024-03-05
- First posted
- 2021-08-18
- Last updated
- 2024-06-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05011162. Inclusion in this directory is not an endorsement.